Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

All eligible patients were randomized to one of the 2 arms in a 1:1 ratio for 26 weeks of treatment.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

A total of 523 patients were randomized. A total of 522 patients (99.8%) were included in the Full analysis Set (FAS) and Safety set. One patient was excluded who was randomized in error and did not receive study medication.

Reporting Groups

Description

QVA149

Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.

Fluticasone/Salmeterol

Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

QVA149

Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.

Fluticasone/Salmeterol

Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed via spirometry. A positive change from baseline in FVC indicates improvement in lung function.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.

Reporting Groups

Description

QVA149

Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.

Fluticasone/Salmeterol

Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

The total score of the St. George's Respiratory Questionnaire (SGRQ-C) is a health related quality of life questionnaire consisting of 51 items in three components: symptoms, activity, and impacts. The lowest possible value is zero and the highest 100. Higher values correspond to greater impairment in quality of life.

Time Frame

12 weeks and 26 weeks

Safety Issue

No

Population Description

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

The Full Analysis Set (FAS) includes all randomized patients who received at least one dose of study drug. FAS were used to analyze all efficacy endpoints, unless otherwise stated. Following the intention-to-treat principle, patients in the FAS were analyzed according to the treatment they were randomized to.

Reporting Groups

Description

QVA149

Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.

Fluticasone/Salmeterol

Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Measured Values

QVA149

Fluticasone/Salmeterol

Number of Participants Analyzed
[units: participants]

230

238

Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)
[units: units on a scale]Least Squares Mean ± Standard Error

12 weeks (n=230 QVA149; 238 flut/salm)

36.74
± 1.175

36.03
± 1.132

26 weeks (n=211 QVA149; 216 flut/salm)

35.45
± 1.448

36.68
± 1.386

No statistical analysis provided for Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)

7. Secondary:

Mean Change From Baseline in Daily Number of Puffs of Rescue Medication [ Time Frame: Baseline, 12 weeks and 26 weeks ]